VP Genomic Research – genomic test development for molecular diagnostics
VP Genomic Research, Los Angeles CA
VP Genomic Research needed to manage operational and logistical tasks of genomic test development to ensure efficient execution of studies for molecular diagnostic products within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations. The candidate will be responsible for designing the test development process, directing a team of molecular biologist, computational biologists, and clinical scientists.
- Understanding of immunology and blood based disease identification preferred as well as a strong understanding of computational biology
- Masters, PhD or MD degree in related field preferred
- Experience in molecular diagnostic product development with at least five years of hands-on managerial experience
- Strong knowledge of FDA regulations and internal regulations
- Knowledge of and experience in experimental design
- Basic understanding of statistics and statistical methods
Role and Responsibilities:
- Set strategic direction and lead new genomic test development efforts.
- Develop and maintain professional relationships with academic, Key Opinion Leaders (KOLs) and community-based physicians to assure good clinical input to product development process, marketing, and field sales force.
- Author and/or work with others to develop publications based on the results of the clinical studies trials.
- Provide updates and status reports to senior management on a regular basis; report on performance against plan.
- Manage the budget for new test development efforts. Ensure overall operation is within the approved budget and timeline.
- Work with Product Development to ensure effective transfer of new tests
- Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with patients and physicians.
- Interface with departments within and outside including Reimbursement, R&D, Regulatory Affairs, Marketing, and Sales.
- Manage staff and outside partners/service providers.
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